Comparison of Basic Regulatory Requirements for Generic Drug Products Registration in CIS and Latin American Countries

Author(s): Mohit, Aakash Deep*, Gaurav Khurana, Jagdeep Kumar, Akshay Monga

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 2 , 2020

Graphical Abstract:


The product registration in the rest of the World is a challenging task because the regions under it are not harmonized. CIS and Latin American regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. Both the regions follow their regional checklist for Drug Product Registration. Latin America includes a group of countries like Brazil, Guatemala and Peru etc, whereas CIS includes Russia, Ukraine, Uzbekistan, Armenia and Tajikistan etc.

Keywords: Generic drug, latin American regions, regulatory requirements, product registration, LATAM region, administrative documents.

Basak S. Pharmaceutical market and regulatory contents for export of pharmaceutical products to Latin American Countries. IOSR J Pharm 2018; 8(4): 60-72.
Handoo S, Arora V, Khera D, Nandi PK, Sahu SK. A comprehensive study on regulatory requirements for development and filing of generic drugs globally. Int J Pharm Investig 2012; 2(3): 99-105.
[] [PMID: 23373001]
[3] 2019.CIS Countries Available from:,12.htm
Mohak V, Charmy K, Manan S. Regulatory technicalities for drug product registration in Brazil. Int J Drug Regulatory Affairs 2017; 5(4): 18-25.
Sravani M, Kusuma SM, Prabhahar AE, Nadendla RR. Registration of generic drugs in central America and Mexico. Int J Pharm Chem Res 2017; 3(3): 635-50.
Sri SB, Prabahar AE. current scenario of generic drug regulation and registration process in Latin America Countries. Int J Pharm Chem Res 2017; 3(4): 857-78.
Choudhary A. Climatic zones for stability studies Pharmaguidelinecom 2019 Available from:
[8] State registration of medicinal products in Russia, drugs registration 2019 Available from: ucts-russia.html
Badjatya J, Bodla R, Musyuni P. Export registration of pharmaceuticals in rest of world countries (row). J Drug Del Therapeut 2013; 3(1): 61-4.
Pharmabiz: Drug registration requirements for various countries Pharmabizcom 2019 [cited: 10 Jan 2019] Available from: ountries/Russia.aspx
State registration of medicinal products in Ukraine Mspua 2019; [cited 10 April 2019] Available from:
Praneetha K, Prakash B, Umasankar K, Alagusundaram M, Jayachandra RP. Study on the regulatory requirements for registration of pharmaceuticals for human use in common wealth of independent states. J Sci 2014; 4(8): 486-504.
Sate registration of medicinal products in Kazakhstan; [cited 17 Jan 2019] Available from:
State registration of medicinal products in Uzbekistan Mspcorporatecom 2019; [cited 20 Feb 2019] Available from:
Intellectual Property Protection in Eastern Europe | PETOŠEVIĆ Petoseviccom 2019; [cited 26 Feb 2019] Available from
Scientific center for drug and medical technology expertise after academician E Gabrielyan; [cited 12 March 2019] Available from:

open access plus

Rights & PermissionsPrintExport Cite as

Article Details

Year: 2020
Page: [117 - 125]
Pages: 9
DOI: 10.2174/2213476X06666191023093840

Article Metrics

PDF: 27